Suitability of BBraun NRFit Lock Syringes with BBraun NRFit Syringe Caps for storage of injectable medicines

Tim Root, Assistant Head, Medicines Assurance, NHS Specialist Pharmacy Service, Specialist Pharmacy ServicePublished

The NHS Pharmaceutical Aseptic Services Group published its requirements for the introduction of NRFit neuraxial syringes and caps for the purposes of drug storage on 13th October 2016. This is necessary as, in line with other standard plastic syringes, these are CE marked for the administration of drug products but not for storage. In order to allow aseptic facilities to draw up medication in advance and store ahead of administration the additional data was requested.

BBraun NRFit syringes in combination with BBraun NRFit Syringe Caps can be safely used for short term
storage of intrathecal drugs, this applies across the whole range of sizes. The shelf life of these products can
be in line with that used in other validated syringe and closure combinations. This is of course limited to
seven days in aseptic units operating under section 10 exemption where suitable drug stability data exists
to cover this period. Units working under a Specials Licence can assign a longer shelf life where stability
data and in-house process validations support this. For all units NRFit syringes should be included in
ongoing media validation studies or other relevant process / product validation studies as appropriate.